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临床试验/NCT02307981
NCT02307981Unknown不适用

Management and Outcome of Visual Field Defects in Occipital Infarction (NOR-OCCIP)- A Multi-center Prospective Study

Haukeland University Hospital2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
75
试验地点
2
主要终点
Visual Field defect

研究概览

简要总结

Patients who suffer an ischemic stroke in the occipital lobe often experience Visual Field defects. Visual Field defects are negatively correlated to falling, institutionalisation, rehabilitation outcome and quality of life. Patients are often not properly examined and seldom receive rehabilitation. NOR-OCCIP aims to evaluate the Natural history of Visual Field defects after occipital infarction and to determine whether rehabilitation is effective.

详细描述

BACKGROUND: Visual Field defects after cerebral infarction is an increasingly acknowledged problem, which has consequences for patient outcome. The aim of the Norwegian Occipital Ischemic Stroke Study (NOR-OCCIP) is to: 1.) Improve clinical diagnostics and management of visual field defects in occipital stroke. 2.) Identify and estimate the need for visual rehabilitation among patients with VFD by studying the natural course and the rate of spontaneous recovery. 3.) Study the effect of visual rehabilitation both on visual function as well as on quality of life. METHODS: Patients with acute ischemic occipital stroke on MRI are recruited from Bergen, Stavanger and Trondheim. Patients are included for a period of 1.5 years, starting August 15th 2013. Patients are eligible for inclusion if >18 years, written consent is obtained and the patient is able to co-operate to examination with autoperimetry. Within one week patients are examined by ophthalmologist after a standardized protocol including autoperimetry. During week four patients are examined by vision teacher after a standardized protocol and a structured interview on vision specific function and quality of life (VFQ-25) is conducted by a study nurse via telephone. If visual rehabilitation is provided by the municipality in which the patient lives, the patient will be referred to such. Eye examination including autoperimetry, vision teacher assessment and VFQ-25 is repeated after 6 months. All patients will be registered in the national stroke registry, and the following variables will be analysed: Demographic variables, lifestyle factors, clinical status at admission (scores on NIHSS), clinical status at discharge and 3 months post-stroke (scores on modified Rankin Scale). So far 62 patients have been included. Limited research exists on visual impairment after cerebral infarction. It is important to establish the natural course of visual impairment after ischemic stroke, and to evaluate the effect of visual rehabilitation.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Written consent obtained,
  • age >18,
  • acute occipital infarction on brain imaging and ability to cooperate for examination with autoperimetry

排除标准

  • Pathological processes that severely affect eyesight.

结局指标

主要结局

Visual Field defect

时间窗: 6 months

Change in Visual Field defect as measured by autoperimetry

次要结局

  • Change in Visual function(6 months)
  • Quality of life and self reported Visual function(6 months)
  • NIHSS(One week)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristin Modalsli Sand

Kristin Modalsli Sand MD

Haukeland University Hospital

研究点 (2)

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Norwegian Occipital Ischemic Stroke Study | 临床试验